Label: JNN-II CLEAN TOK HAND GEL- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 24, 2020

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  • PRINCIPAL DISPLAY PANEL

    CLEAN TOK HAND GEL

    Active ingredient

    Alcohol 70% w/w

    Purpose

    Antiseptic

    Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    ■ in children less than 2 months of age ■ on open skin wounds

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    ■ Take an appropriate amount on your hands, and then spread evenly. Rub hands together until dry.

    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

    ■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)

    ■ This product is intended only for hand sanitizing.

    Other information

    ■ Store between 15-30 °C (59-86 °F)

    ■ Avoid freezing and excessive heat above 40 °C (104 °F)

    Inactive ingredients

    Water, Butylene Glycol, Carbomer, Triethanolamine, Fragrance, Chamaecyparis Obtusa Leaf Extract, Biota Orientalis Leaf Extract, Nelumbo Nucifera Leaf Extract, Pinus Densiflora Leaf Extract, Bambusa Vulgaris Extract, Avena Sativa (Oat) Meal Extract, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, 1,2-Hexanediol, Maltodextrin

  • INGREDIENTS AND APPEARANCE
    JNN-II CLEAN TOK HAND GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78424-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL14 mL  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)  
    PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)  
    OATMEAL (UNII: 8PI54V663Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78424-020-0120 mL in 1 POUCH; Type 0: Not a Combination Product09/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2020
    Labeler - JOY LIFE Co., Ltd. (689846233)
    Establishment
    NameAddressID/FEIBusiness Operations
    JOY LIFE Co., Ltd.689846233manufacture(78424-020)